23 Attorneys General Urge FDA to Ensure Affordable Access to Insulin

September 2, 2020 – Michigan Attorney General Dana Nessel has joined a bipartisan coalition of 23 attorneys general in signing a letter urging the Food and Drug Administration (FDA) to prohibit use of the publication “Approved Drug Products with Therapeutic Equivalence Evaluation” – commonly known as the Orange Book – to block competition.

The Orange Book enables branded drug manufacturers to obtain an automatic 30-month suspension of the FDA’s approval of any potential generic competitor claiming a listed patent.

“Michiganders are among the millions of people across this country who depend on their insulin doses to make it through each day and they shouldn’t have to ration those doses simply because of a technicality that impedes their access to affordable medicine,” said Nessel. “My colleagues and I are urging the FDA to take action to ensure their processes don’t stand in the way of more affordable drugs.”

In the letter — a response to a call for public comment by the FDA — the attorneys general express their concern with the affordability of drugs and devices and call on the FDA to prohibit companies from listing device and component patents in the FDA’s Orange Book.

Attorney General Nessel joins the attorneys general of Alaska, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Minnesota, Mississippi, Montana, Nevada, New Mexico, Oregon, Puerto Rico, Rhode Island, Virginia, Washington, and Wisconsin in submitting the comment letter.

By Mid-Michigan Now Newsroom
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